The present application is related to U.S. Pat. No. 6,254,595 and U.S. Pat. No. 6,344,040, the disclosures of which are incorporated herein by reference.
1. Field of the Invention
The present invention relates to an interface device for ophthalmic laser surgery and, more particularly, an interface apparatus used to stabilize the eye of a patient with respect to a laser beam during ophthalmic surgery, and to reconfigure the cornea for precision laser interaction.
2. Background
In recent years, significant developments in laser technology have led to its application in the field of ophthalmic surgery. In particular, laser surgery has become the technique of choice for ophthalmic surgical applications. In certain ophthalmic laser procedures, surgeons use a mechanical device termed a microkeratome to cut a layer of the anterior surface of the cornea in order to expose the underlying corneal stroma to which the laser is applied. However, complications surrounding the use of the microkeratome and its metal blade have resulted in research into improved techniques that are performed exclusively by a laser system. Such all-laser techniques obviate the need for mechanical devices pre- or post-operatively, and provide significantly improved precision.
Despite these advances in laser technology, the use of such systems for ophthalmic surgical procedures remains fraught with substantial mechanical limitations, particularly in the area of developing a stable interface between an incident laser beam and the eye of a patient. Ophthalmic surgery is a precision operation and requires a very precise coupling between the surgical tool (i.e., the laser beam) and the region to be disturbed (i.e., a portion of the patient's eye). Even a very small movement of the eye with respect to the intended focal point of the laser beam can not only lead to non-optimal results, but might even result in permanent damage to non-renewable tissue within the eye, leading to precisely the opposite result than that desired. Given that eye movement is often the result of autonomic reflex, it should be understood that there must be some means of stabilizing the position of a patient's eye with respect to an incident laser beam in order to avoid the intolerable consequence of relative movement.
Heretofore, the major technique used to compensate for relative eye motion with respect to an incident laser beam, has been to have the patient focus on a stationary target. This involves providing a visual target to the eye undergoing surgery, and requiring that the patient retain focused on the perceived target feature. While this technique has provided some small benefit, it places all of the burden of minimizing relative motion upon the patient, and does not allow for any gross autonomic reflex motions, e.g., as when the patient might be startled. In this technique, the target provides optical interface, while the patient's conscious responses provide the feedback mechanism.
An additional technique involves the use of an optical eye tracking apparatus, whereby a selected eye feature is targeted for monitoring by an optical device, and as the targeted feature displaces as the result of eye movement, its displacement is characterized and fed into the incident laser beam control apparatus as a compensation signal. This second technique offers a substantial improvement over the first, particularly when it is implemented in addition to a patient-driven target focusing mechanism. However, such systems are inordinately expensive since a second, completely independent optical path must be provided between a patient's eye and a surgical apparatus in order to accommodate the eye tracking apparatus. Further expense and complexity is incurred when it is considered that an eye tracking apparatus requires an additional software component in order to be operative, which software component must be integrated into a laser delivery system. Considerations of interoperability must be met as well as the provision for an automatic shutdown of the laser system in the event of the loss of target feature lock.
Accordingly, a simple mechanical system, if properly designed, is able to best meet the imperatives of interfacing a laser delivery system with a target object. If the goal is to minimize relative analog motion, an analog stabilization device would necessarily offer the most advantageous solution. In this regard, certain mechanical stabilization devices have been proposed, particularly, a corneal applanation device which is the subject of U.S. patent application Ser. No. 09/172,819, filed Oct. 15, 1998 and commonly owned by the assignee of the present invention, the entire contents of which are expressly incorporated herein by reference. Such a mechanical device directly couples a patient's eye to the laser's delivery system being affixed to both the laser and the anterior surface of a patient's cornea. The corneal coupling, in these devices, is typically implemented by lowering an applanation fixture over the anterior surface of the cornea under pressure. It is assumed in these forms of devices that pressure applied normal to the corneal surface will restrict conventional motion of the cornea thereby stabilizing the eye along a major access normal to the device.
However, although this assumption may hold true in a large number of cases, it certainly interface should be established with the iris centered, for best results. The actual establishment of an effective device/corneal interface is an exercise in trial-and-error, resulting in a great deal of frustration to doctor and patient, as well as considerable eye fatigue.
For ophthalmic laser procedures where eye tissue is to be photodisrupted, it is extremely important for the laser beam to be properly focused to a specific focal spot in the tissue that is to be effected. Not only is it extremely important to have good focal definition, but also that the focal point have the proper dimensionality (i.e., the correct spot diameter and shape). In order to accommodate this, it is necessary for the laser beam to be as free from aberrations as possible. In particular, for ophthalmic laser procedures involving the cornea, it happens that the spherical geometry of the cornea introduces optical aberrations as a result of its shape, which are separate and distinct from aberrations introduced by the laser's own optical system. Significantly, these corneal induced aberrations distort the definition of the focal spot of a laser beam as the beam is focused to a position within corneal tissue.
Due to the spherical geometry of the anterior surface of the cornea, two specific types of aberrations are of particular importance with regard to beam distortion; spherical aberration (which relates to points on the optical axis of the laser beam) and coma which relates to points that are off-axis). Spherical aberration and coma are similar to one another in that they both arise from a failure to image or focus optical ray traces onto the same point. Spherical aberration relates to a distortion that can be characterized as radial in nature, with some radial directions being stretched while other radial directions are shrunk, converting thereby, an ideally circular spot into an elliptical spot. Coma distortion, on the other hand, implies an elongation along one radius a circle, resulting in a “comet-like” shape. Accordingly, any structure which interfaces between a curved, anterior surface of the cornea and laser delivery system must be applanatic in nature. By definition, an applanatic lens is one which is free from both spherical aberration and coma.
As is recognized by the present invention, applanatic refraction at the anterior surface of the cornea can be effectively accomplished by flattening the anterior surface. With such a corneal reconfiguration, the beam will be free of aberrations (other than chromatic) which would otherwise result from an interface with the cornea's native spherical anterior surface.
In view of the foregoing, it is thus evident that there is a need for a simple mechanical interface device that is able to stabilize the eye against relative motion with respect to a laser beam used for ophthalmic surgical procedures without relying on secondary mechanical considerations, such as surface tension, friction, or the like. Such a device should be able to present an optical feature to an incident laser beam in a stable, well characterized location, such that the beam is able to interact with the feature without regard to opto/electronic feedback mechanisms. In addition to maintaining a proper orientation between the eye and a laser delivery system during ophthalmic laser surgery, such a device should applanate the eye during surgery while reducing inter-ocular pressure during the surgical procedure. Such a device should be easy for a clinician to affix, as well as being simple and cost effective to manufacture and use.